Rx15 ea wed_1230_1_frattaroli_2kolodny_3chan_4cahana

Education and Advocacy Track:A Consensus Roadmap to Curb

Deaths from Rx Drug Misuse and Abuse in the U.S.

Presenters:

• Shannon Frattaroli, PhD, MPH, Associate Professor of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, and Associate Director for Outreach, Center for Injury Research and Policy

• Andrew Kolodny, MD, Chief Medical Officer, Phoenix House Foundation, Inc., and Director of Physicians for Responsible Opioid Prescribing

• Alexander Chan, MPA, MCM, Associate Director of National Strategy, Clinton Health Matters Initiative

• Alex Cahana, MD, Professor in Pain Medicine and Bioethics, University of Washington

Moderator: Nancy Hale, President and CEO, Operation UNITE

Disclosures

Shannon Frattaroli, PhD, MPH; Andrew Kolodny, MD; Alexander Chan, MPA, MCM; Alex Cahana, MD; and Nancy Hale have disclosed no relevant, real, or apparent personal or professional financial relationships with proprietary entities that produce healthcare goods and services.

Disclosures

• All planners/managers hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.

• The following planners/managers have the following to disclose:– Kelly Clark – Employment: Publicis Touchpoint Solutions;

Consultant: Grunenthal US– Robert DuPont – Employment: Bensinger, DuPont &

Associates-Prescription Drug Research Center– Carla Saunders – Speaker’s bureau: Abbott Nutrition

Learning Objectives

1. Research the Clinton Foundation’s national, cross-disciplinary team charged with identifying Rx drug abuse strategies.

2. Outline the team’s recommendations for strategies to reverse alarming trends in opioid related injuries and deaths.

A Consensus Roadmap to Curb Deaths from Prescription Drug Misuse and

Abuse in the United States

Context of Our Initiative

Community-based Prevention Strategies

Shannon Frattaroli, PhD, MPHThe Johns Hopkins Bloomberg School of Public Health Center for Injury Research and Policy

Disclosure

• Shannon Frattaroli, PhD, MPH, has disclosed no relevant, real, or apparent personal or professional financial relationships with proprietary entities that produce healthcare goods and services.

Consensus Roadmap Background

• Johns Hopkins Bloomberg School of Public Health and the Clinton Health Matters Initiative

• Identifying Experts

• Town Hall

• Expert Meeting

• Post-Meeting Commitments

Consensus Roadmap Working Groups

• Engineering strategies: Rx drugs and packaging

• Prescribing guidelines

• Prescription drug monitoring programs

• Naloxone distribution

• Community-based prevention strategies

• Addiction treatment

• PBMs and Pharmacies

Working Groups’ Charge

• Draft a Report

– Statement of the Problem

– Synthesis of Available Evidence

– Recommendations for Action

– Communications Recommendations

Plan for the Consensus Roadmap

• Annual Event

• Report Release

• Engagement with New Stakeholders

• Dissemination Strategy

• Next Steps


• Statement of the Problem

– There is no organized community approach to primary prevention of OPR misuse and abuse


• Synthesis of Available Evidence

– OPRs: Activity vs. Evidence• Harm reduction• Prevention

– Lessons from Other Topics • Antibiotic use and children• Alcohol• Other substances


• Recommendations for Action: Focus on Specific Populations

– School Children

– College Students

– Substance Users

– Acute Pain Patients

– Chronic Pain Patients

– General Public


• Communications Recommendations

– Funders and the need for evaluations of community-based interventions

– Varied stakeholders and the need for storage and disposal interventions

– Policymakers (legislative and executive) at the state and local levels and opportunities for leadership on this issue

Contact Information

Shannon Frattaroli

[email protected]

Responding to North America’s

Opioid Addiction Epidemic

Andrew Kolodny, M.D.Chief Medical Officer, Phoenix House Foundation Inc.Executive Director, Physicians for Responsible Opioid PrescribingSenior Scientist, Heller School for Social Policy and Management, Brandeis UniversityResearch Professor, Global Institute of Public Health, New York University

Disclosures

• Andrew Kolodny, MD, has disclosed no relevant, real, or apparent personal or professional financial relationships with proprietary entities that produce healthcare goods and services.

How the opioid lobby frames the the Rx problem

Source: Slide presented by Lynn R. Webster MD at FDA meeting on hydrocodone upscheduling, January 25th, 2013.

Pain Patients “Drug Abusers”

63% admitted to using opioids for

purposes other than pain1

35% met DSM V criteria for

addiction2

1. Fleming MF, Balousek SL, Klessig CL, Mundt MP, Brown DD. Substance Use Disorders in a Primary Care Sample Receiving

Daily Opioid Therapy. J Pain 2007;8:573-582.

2. Boscarino JA, Rukstalis MR, Hoffman SN, et al. Prevalence of prescription opioid-use disorder among chronic pain patients:

comparison of the DSM-5 vs. DSM-4 diagnostic criteria. J Addict Dis. 2011;30:185-194.

This is a false dichotomy

92% of opioid OD decedents

were prescribed opioids for

chronic pain.

3. Johnson EM, Lanier WA, Merrill RM, et al. Unintentional Prescription Opioid-Related Overdose Deaths: Description of

Decedents by Next of Kin or Best Contact, Utah, 2008-2009. J Gen Intern Med. 2012 Oct 16.

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Source: Kolodny et al. The Prescription Opioid and Heroin Crisis: A Public Health Approach to an Epidemic of Addiction. AnnuRev Public Health. 2015: 36:559-574

Non-medical use (abuse) of painkillers declining since 2002

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Source: Kolodny et al. The Prescription Opioid and Heroin Crisis: A Public Health Approach to an Epidemic of Addiction. Annu Rev Public Health. 2015: 36:559-574

Non-medical Opioid Users Opioid Overdose Decedents

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Death rates from overdoses of heroin or prescription opioid pain relievers (OPRs), by age group

SOURCE: CDC. Increases in Heroin Overdose Deaths — 28 States, 2010 to 2012 MMWR. 2014, 63:849-854

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Heroin admissions, Age & Race: 2001- 2011

0

2,000

4,000

6,000

8,000

10,000

12,000

14,000

16,000

18,000

20,000

22,000

24,000

26,000

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

Painkillers Heroin Total Opioid

Year

Opioid Related Overdose Deaths

United States, 1999-2013

Source: CDC National Center for Health Statistics

Primary non-heroin opiates/synthetics admission rates, by State(per 100,000 population aged 12 and over)

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27


28


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Controlling the epidemic:A Three-pronged Approach

• Prevent new cases of opioid addiction

• Treatment for people who are already addicted

• Supply control- Efforts to reduce over-prescribing and black-market availability

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Opioid Addiction Treatment

• Psychosocial Approaches

– 12 Step

– Residential

– Cognitive Behavioral Therapy

• Pharmacological Approaches

– Buprenorphine

– Methadone

– Naltrexone

Buprenorphine Experience in France

• Introduced in the mid 90s

• 80% decline in OD deaths in 6 years*

• Associated with diversion and injection use

*Emmanuelli J, Desenclos JC. Harm reduction interventions, behaviours and associated health outcomes in France, 1996–2003. Addiction 2005;100:1690–1700.

Full Opioid Agonists

Buprenorphine- A Partial Agonist

Retention in TreatmentKakko, Lancet 2003

Treatment duration (days)

Rem

ain

ing in t

reatm

ent

(nr)

0

5

10

15

20

0 50 100 150 200 250 300 350

Detoxification

Maintenance

Buprenorphine RCT A Tragic Appendix: Mortality

Kakko, Lancet 2003

Placebo BPN

Dead 4/20 (20%) 0/20 (0%)

Barriers to Buprenorphine

• Ideological

• Federally imposed patient caps

• Federally imposed ban on NP and PA prescribing

• Addiction stigma limiting integration in primary care

• Inertia

Summary

• The U.S. is in the midst of a severe epidemic of opioid addiction

• To bring the epidemic to an end:

– We must prevent new cases of opioid addiction

– We must ensure access to treatment for people already addicted

A Consensus Roadmap to Curb Deaths from Prescription Drug Misuse

and Abuse in the United States

Scaling Access to Naloxone in Communities of Need

Alex Chan has no disclosed relevant, real or apparent personal or

professional financial relationships with proprietary entities that produce

health care goods and services.

Disclosures

The Clinton Foundation helps transform lives and

communities from what they are today to what they can

be by creating partnerships of great purpose to deliver

sustainable solutions and empower people to live better

lives.

Clinton Foundation Purpose & Approach

Clinton Health Matters Initiative

What We Do

• Build strategic partnerships that will help facilitate the development and scaling of health promoting solutions.

• Work across sectors to develop and implement coordinated, systemic approaches to creating healthier communities.

• Leverage technology and digital innovation to help advance health and wellness at the national and community levels by disseminating evidence-based individual, systems, and investment strategies.

Prescription Drug Abuse & Misuse

Goal: The Clinton Foundation seeks to cut prescription drug abuse deaths in half – saving approximately 10,000 lives – through strategic

partnerships that raise consumer and public awareness, advance business practice change, and

mobilize communities.

The Campus Program

Johns Hopkins

Partnership

Scaling Access to Naloxone

Why Naloxone?

1. In the US in 2010, opioid analgesics, such as oxycodone, hydrocodone, and methadone, were involved in about 3 of every 4 pharmaceutical overdose deaths (CDC, 2013).

2. Most prescription opioid deaths occur outside of medical settings (Paulozzi , 2012).

3. The number of community-based overdose education and naloxone distribution (OEND) programs has been on the rise; at least 188 community-based programs were in existence in the US in 2010 (Wheeler, Davidson, Jones, & Irwin, 2012).

4. Data from a 2010 survey found that 48 OEND programs in the US had trained and provided naloxone to over 50,000 individuals between 1996 and 2010, and reported over 10,000 opioid overdose reversals during this time (Ibid) .

Starting Points

•April 2014•25 Cross-sectorial •Identified barriers and

Naloxone Working Group

•May 2014•25 Representatives across

and sectors•Identified common agenda

established 7 key priorities

Johns Hopkins Working Group

Naloxone Purchasing Agreement

s

Barriers to Usage

• Lack of awareness of naloxone across a complex healthcare delivery system

• CMS: Engaging CMS in the conversation

• Role of business • Stigma: as it applies to 1) individuals;

2) community (cultural acceptance); 3) people/ organizations (i.e. law enforcement) that are promoting naloxone access

• Training: Need for professional training; not well defined currently

• Laws: Numerous laws need to be addressed that prevent access

• Lack of Data:• Need for better data to support

different prevention and organizational recommendations

• Need for better data about cost-effectiveness of Naloxone

• Need for data about co-prescribing

• Politics: the different ideologies that are likely to clash

• Lack of unified message• Money: Someone needs to pay for

this; thinking about how other groups might be able to pay

• Affordability • Accessibility of naloxone in the

physical space • Confidentiality: Issue of

confidentiality and the lack of sharing information

• Coverage • Criteria for Use of naloxone • Communication to patients +

individuals

Barriers to Usage: Training

• Integrating Naloxone education into a variety of education programs; certifications; and surveys

• Lack of accessible CME content through different mediums for a variety of groups • How to develop content that

people want to learn • No clear framework on how to get

doctors to “buy-in”• Making Naloxone access a norm ( i.e.

seatbelt : following a road safety norm)

• Messaging ( i.e. how to position this as a universal precaution) • How to translate this technical

space into something that is engaging

• Putting message into untraditional + “edgy” forms

• Org taking Leadership role: Who is taking the leadership role? What is their responsibility?

• Education: Educating patients on how to educate caregivers

• Lack of awareness in understanding overdose

• CME: Time, interest and incentive to schedule this into your CME

• Training: Time, interest and incentive to create broader training; Integrating training into the collective bargaining process

• Antiquated training system • Lack a standard of delivery• Workforce: No workforce for

disseminating this information • Government providing advice and

guidance and developing medical boards

• Lack of understanding of medical legal standard of care

• Figure out ways to work with state and national boards

Barriers to Usage: Community Access

• Developing syringe exchange framework

• Catalyzing parent involvement• Risk of overdose is more privatized• Barriers around the law: what is legal?• Issues of stigma and community

perception• Issue of warm hand-off to treatment • Funding for the community &

coverage • Lack of integration in the healthcare

system ( i.e. education, advocacy) ; how do you make it apart of the whole solution?

• Education between prescription and using Naloxone

• Developing a pharmacy care model; what’s pharmacy’s role?

• Stuck in a prescription model • Mode of delivery; how to make it

more accessible • Shelf life of Naloxone ( awareness) • Complexity of system • Availability and accessibility

What’s Working

• Reversal success is self-perpetuating • Re-define community groups :

success with law enforcement and first responders

• All EMTs (local and rural) will be trained

• Naloxone distribution with education + awareness campaigns through a variety of channels - expanding the definition of gate-keepers to include places such as local schools

• Leadership investment changes what the outcomes are

• Needle exchange programs• Collaborative practice agreements • Professional association expectation• Needing better models on education

(Rhode Island model is very promising)

• Building on the REMS Framework• Developing new aspects to

Prescription Drug Monitoring Programs - incorporate pharmacy benefit managers as well as insurance companies as well

• Create evidence-base and more effective educational messages

• Getting attention of doctors on how it is effecting their patient population

• Developing guidelines on who to prescribe Naloxone to

• Creating new terminology• Improving supply chain • Improving the standard of care• Making it user-friendly• Empowering parents (i.e. moms) to

be heroes and working with families

• Emphasis on prevention (addressing over prescribing), education and awareness

• Building strong community partnerships (i.e. law enforcement)

• Exercise caution when labeling things as “safe”

• Making it widely available through simplicity and accessibility ( i.e. community centers)- Finding ways to meet people

where they are

What Does Success Look Like?

1. Provide a predictably affordable supply of Naloxone to community groups, creating a window of opportunity for the naloxone distribution field to scale over the next four years.

2. Expand digestible and engaging continuing medical education on naloxone targeting doctors, nurses, dentists, pharmacists and others.

3. Accelerate efficient and rigorous implementation of community-based distribution and access efforts.

Negotiated Agreement Experience

• 2002: CHAI negotiates discounts for antiretroviral medicine in Sub-Saharan Africa

• 2004: AHG brokers beverage industry agreement.

• 2006: CHAI and UNITAID expand coverage to pediatric ARV in developing countries

• Ongoing: AHG supports employers who adopt the Healthier Generation Benefit.

Purchasing Agreements & Partnerships

1. Negotiate agreements with manufacturers of all forms of naloxone, including inhalants, injectables, and other forms under development.

2. Determine appropriate pricing mechanism that allows public safety agencies and community based organizations to purchase naloxone at a discount close to federal pricing.

3. Develop purchasing platforms and mechanisms to assist qualified organizations to participate in the discount pricing program.

Initial Target Audiences

1. Campus Program Colleges• 80 Schools• 23 States

2. Public Safety Agencies & Community Based Organizations• Houston, TX• Jacksonville, FL• Little Rock, AR• Coachella Valley, CA• Adams County, MS

Timeline

A Consensus Roadmap to Curb Deaths from Prescription Drug Misuse and

Abuse in the United States

Legislative and Policy Remedy

The story of WA state

Disclosures

• Alex Cahana, MD, has no disclosed relevant, real or apparent personal or professional financial relationships with proprietary entities that produce health care goods and services.

Approved learning objectives:

• At the end of the session attendees will be able to describe essential elements within policies that positively impact care for patients who are candidates for opioid therapy

• Describe recommendations to improve state policies

Reference:

Franklin G, et al, Am J Public Health, 2015

AMDG Guidelines

• In response to opioid related deaths in WA

• April 2006 AMDG (Medicaid; worker’s comp; DoCorr; DoH; Public employees) convened

• w/ UW, private practitioners; 5 x 3h meetings

• Consensus Guidelines

• 120mg/d MED yellow flag

• April 2007 educational pilot

www.agencymeddirectors.wa.gov

Voluntary educational efforts

• 35 Category I CME presentations to primary care

• 2 hour free category I online test

• WSMA endorsement

• AHRQ endorsement

• In 2009, web based survey:

• 45% were familiar and applied guidelines

• 54% who treat pain patient have concerns

• 86% believe 120mg MED is reasonable or too high

Results from Workers compensation:

ESHB 2876 (2010)

• Repeal WAC 246-919-830 from December 1999

• “no disciplinary action will be taken against a practitioner based solely on the quantity or frequency of opioids prescribed”

ESHB 2876 mandated:

• Use of Opioid dosing criteria (AMDG)

• Guidance on when to seek pain consultation (TeleHealth)

• Guidance on tracking adherent use of opioids (PDMP)

• Guidance on tracking clinical progress focusing on pain interference, mood and function

Rules: 2011

Other legal remedies:

• ESHB 2127: requiring ED opioid guidelines

• ESHB 1370: Take back medicine programs

• ESHB 5516: Samaritan law

• ESHB 1671: Increased access to Naloxone

• ESHB 1403: Paying for TeleMedicine

Health Impact

Recommendations:

http://www.cdc.gov/phlp/publications/topic/prescription.html

Pain & Policy Study group, 2014www.painpolicy.wisc.edu

Education and Advocacy Track:A Consensus Roadmap to Curb

Deaths from Rx Drug Misuse and Abuse in the U.S.

Presenters:

• Shannon Frattaroli, PhD, MPH, Associate Professor of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, and Associate Director for Outreach, Center for Injury Research and Policy

• Andrew Kolodny, MD, Chief Medical Officer, Phoenix House Foundation, Inc., and Director of Physicians for Responsible Opioid Prescribing

• Alexander Chan, MPA, MCM, Associate Director of National Strategy, Clinton Health Matters Initiative

• Alex Cahana, MD, Professor in Pain Medicine and Bioethics, University of Washington

Moderator: Nancy Hale, President and CEO, Operation UNITE

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